FDA.reportPublic FDA data

SEIRIN PYONEX NEEDLES

Primary DI
04547248420024
Brand
SEIRIN PYONEX NEEDLES
Company
SEIRIN CORPORATION
Model
Pyonex Yellow 0.15x0.6mm
Device description
Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. With SEIRIN's consistently smooth insertion, the result is a pleasant and painless experience for your patient.
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547248420021PackageGS110In Commercial Distribution
04547248420024PrimaryGS10
24547248420028Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724842002114547248420021
04547248420024045472484200244547248420024
2454724842002824547248420028

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.6Millimeter
Outer Diameter0.15Millimeter

Contacts#

Phone, Email table
PhoneEmail
800 722 8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
693307373
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547248022105SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x15mm2026-02-11
04547248022167SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.2(0.18)x30mm2026-02-11
04547248420109SEIRIN PYONEX NEEDLESPyonex 0.20x1.7mm2026-02-11
14547248022102SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x15mm2026-02-11
14547248022164SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.2(0.18)x30mm2026-02-11
14547248420106SEIRIN PYONEX NEEDLESPyonex 0.20x1.7mm2026-02-11
04547248420017SEIRIN PYONEX NEEDLESPyonex Orange 0.11x0.3mm2017-08-22
04547248420031SEIRIN PYONEX NEEDLESPyonex Green 0.17x0.9mm2017-08-22
04547248420048SEIRIN PYONEX NEEDLESPyonex Blue 0.20x1.2mm2016-04-01
04547248420062SEIRIN PYONEX NEEDLESPyonex Pink 0.20x1.5mm2016-04-01
04547248240264SEIRIN ACUPUNCTURE NEEDLEKB-Type No.3(0.20)X90mm2016-12-19
04547248240288SEIRIN ACUPUNCTURE NEEDLEKB-Type No.3(0.20)x150mm2016-12-19
04547248240431SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x75mm2016-12-19
04547248240448SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x90mm2016-12-19
04547248240455SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x120mm2016-12-19
04547248240462SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x150mm2016-12-19
04547248240523SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x75mm2016-12-19
04547248240530SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x90mm2016-12-19
04547248240547SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x120mm2016-12-19
04547248240554SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x150mm2016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27